Hello dear listeners, welcome back to The Lawyers Talk channel of BLawyers Vietnam. My name is Huynh Ngoc Uyen Chi, and nice to see everyone on today's Podcast. Today, I will join our esteemed listeners in exploring the process of applying for a Certificate of Free Sale for type B medical devices.
Firstly, I will provide some general information about this type of Certificate before speaking about the main content of today’s topic. A Certificate of Free Sale, commonly abbreviated as CFS, is a certificate issued by a competent state authority of an exporting country to an exporter to certify that goods are allowed to circulate freely in the exporting country. The Government regulates the List of goods and CFS management authority in Appendix V of Decree No. 69/2018/ND-CP, amended by Decree No. 96/2023/ND-CP. Accordingly, medical devices are goods under the CFS-issuing authority of the Ministry of Health. Medical devices are specifically classified by enterprises into types A, B, C or D depending on the level of risk according to the classification rules specified in Appendix I of Circular No. 05/2022/TT-BYT and implementation of the Notification procedures of the Department of Health where the manufacturing facility is headquartered.
The process of applying for a CFS is strictly and complexly regulated by various legal documents, which can easily cause enterprises to miss certain aspects of the process and face difficulties in the actual implementation process. Thus, I will provide a brief and easy-to-understand system of the implementation process, application components, fees and related notes to help enterprises apply for CFS more easily. Please note that, within the scope of today's Podcast episode, we will focus on the procedure for obtaining CFS for type B medical devices with low medium risk level – as the most common type of medical device nowadays. For medical devices classified as type A, C, or D, enterprises should review and note the different regulations and implement procedures in accordance with legal requirements.
Pursuant to current regulations, the procedures mentioned, except for the CFS application procedure at the final step, will be conducted 100% online in parallel at:
(i) The Public Service Portal of the Department of Health of the province or city where the production facility or business headquarters is located and... To read more, please click here: https://www.blawyersvn.com/20-certificate-of-free-sale-cfs-the-process-of-applying-for-a-certificate-of-free-sale-cfs-for-type-b-medical-devices/
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The above is not official advice from BLawyers Vietnam. If you have any questions or suggestions about the above, or if you would like to collaborate and use BLawyers Vietnam’s legal advisory services, please contact us at info@blawyersvn.com. We will be delighted to hear from you.📀 By: Thu Ha, Chi Huynh, and Chau Dang
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